Beamion PANTUMOR-1: A Phase II, Multicentre, Multicohort, Open-label Trial to Evaluate the Efficacy and Safety of Oral Zongertinib (BI 1810631) for the Treatment of Selected HER2-mutated or Overexpressed/Amplified Solid Tumours
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 588
- 试验地点
- 162
- 主要终点
- Proportion of patients with objective response (OR)
研究概览
简要总结
This is a study for people with advanced cancer for whom previous treatment was not successful. Adults aged 18 and over with advanced cancer with HER2 alterations can join the study. The purpose of this study is to find out whether a medicine called zongertinib helps people with advanced cancers with HER2 alterations. HER2 alterations can cause cancer. Zongertinib inhibits HER2.
Participants are put into groups based on the type of advanced cancer they have, the type of HER2 alterations they have, and the dose of zongertinib they receive. Depending on the group they are in, participants take 1 of 2 different doses of zongertinib each day. Participants can continue the treatment as long as they benefit from it and can tolerate it.
Participants visit the study site regularly. During many of the visits, the doctors check the size of the tumour and whether it has spread to other parts of the body. During all the visits, the doctors check participants' health and take note of any unwanted effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥18 years
- •Documented Human epidermal growth factor receptor 2 (HER2)-positive status or known activating HER2 mutations (by local testing)
- •Histologically or cytologically confirmed locally advanced, unresectable, or metastatic solid tumours
- •Disease progression following prior treatment in the metastatic setting (including treatment with antibody-drug conjugates (ADCs)) and no suitable standard of care treatment options
- •Availability of archival tumour tissue sample to confirm HER2 status
- •Presence of ≥1 measurable lesion outside the central nervous system (CNS) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (investigator assessed)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Further inclusion criteria apply.
排除标准
- •Diagnosis of HER2-positive (overexpressed/amplified) metastatic breast cancer or metastatic gastroesophageal adenocarcinoma
- •Diagnosis of HER2-mutant non-small cell lung cancer (NSCLC)
- •Previous treatment with any HER2 tyrosine kinase inhibitors (TKIs)
- •Previous or concomitant malignancies other than the one treated in this trial within the previous 3 years except the following effectively treated cancers: nonmelanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, localized prostate cancer on watchful waiting or active surveillance, and other effectively treated malignancies that are considered cured by local treatment
- •Uncontrolled or symptomatic brain or subdural metastases during screening
- •Known diagnosis of leptomeningeal disease
- •Intake of restricted medications or any drug considered likely to interfere with the trial being conducted in a safe mannerFurther exclusion criteria apply.
研究组 & 干预措施
Zongertinib treatment
干预措施: Zongertinib (Drug)
结局指标
主要结局
Proportion of patients with objective response (OR)
时间窗: Up to 51 months
according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 by central independent review, and it will be summarised descriptively as absolute and relative frequencies
次要结局
- Change from baseline to Week 48 or progressive disease (PD) by central independent review, if earlier, of the European Organisation for Research and Treatment of Cancer, quality-of-life questionnaire (EORTC QLQ-C30)(At baseline and up to 48 weeks)
- Change from baseline to Week 48 or progressive disease (PD) by central independent review, if earlier, of the EORTC QLQ-C30, which includes IL-19, the physical functioning scale(At baseline and up to 48 weeks)
- Duration of objective response (DOR)(Up to 51 months)
- Progression-Free Survival (PFS)(Up to 51 months)
- Disease control (DC)(Up to 51 months)
- Occurrence of treatment-emergent Adverse Events (AEs)(Up to 51 months)
- Change from baseline to Week 48 or progressive disease (PD) by central independent review, if earlier, in the European Organisation for Research and Treatment of Cancer, quality-of-life questionnaire (EORTC QLQ-C30)(At baseline and up to 48 weeks)
- Overall survival (OS)(Up to 51 months)